We are happy to announce that Bidi Vapor has been granted a stay order by the FDA.
Which means all 11 flavors of the BIDI®️ Stick are now legal to market and distribute as the FDA is currently reviewing the previously released MDO.
MELBOURNE, Fla., (January 26, 2022) — Bidi Vapor LLC, announced results of a newly published study that found its premium electronic nicotine delivery system (ENDS), a disposable device branded BIDI® Stick, mimicked the blood levels of nicotine when subjects smoked their usual brand of combustible cigarette, potentially providing a satisfying alternative to cigarette smoking.
Officials shared the findings at the Tobacco Plus Expo, held from January 26-28, 2022, at the Las Vegas Convention Center, along with the distinctive qualities of the Company’s premium e-cigarette.
In research published in November of 2021, comparative blood samples revealed a dramatic alignment between combustible cigarettes and BIDI® Sticks (both tobacco and flavored products). Dr. Ian Fearon, the paper’s lead author and renowned, U.K.-based nicotine scientist, concluded, “BIDI® Stick ENDS delivered nicotine to users comparably to their usual brand cigarette and also elicited similar subjective effects such as satisfaction and relief.”
Fearon went further to note the study’s implications: “Thus, the BIDI® Stick ENDS may be a satisfying alternative to cigarettes among current adult smokers, including those that find it difficult to quit or who are not interested in quitting smoking.”
Comparing published research on other ENDS and tobacco-containing “heat-not-burn” products, study authors said the BIDI® Stick may have a greater ability to satisfy adult smokers looking for alternative, non-combustible sources of nicotine.
Researchers completed the clinical “pharmacokinetic” or “PK” study in August of this year to assess both the kinetics of nicotine uptake and the subjective experiences in smokers when they used the BIDI® Stick.
The paper, called “A Randomized, Crossover Clinical Study to Assess Nicotine Pharmacokinetics and Subjective Effects of the BIDI® Stick ENDS Compared with Combustible Cigarettes and a Comparator ENDS in Adult Smokers,” described the findings from a study in adult smokers aged 21-65 who smoked at least 10 factory-manufactured cigarettes a day.
In a U.S. Food and Drug Administration (FDA) media briefing held in March 2018, Mitch Zeller, director of the FDA’s Center for Tobacco Products (CTP), called combustible cigarettes the “deadliest” but “most efficient way to deliver nicotine.” Zeller has gone on to say that e-cigarettes have yet to reach the level of providing the satisfaction smokers want. That time may have come, said officials with the Melbourne, Florida-based vaping company.
“This study shows that the BIDI® Stick can be a meaningful, nicotine delivery alternative for adult smokers aged 21 and older,” said Niraj Patel, president and CEO of Bidi Vapor. “We are submitting this data to FDA as part of our Premarket Tobacco Product Application (PMTA) and believe the scientific evidence supports that the BIDI® Stick is appropriate for the protection of the public health.”
With regards to the equally significant concern of underage vaping, Patel said measures designed to curb youth access are addressing the problem. “We at Bidi Vapor have always employed the strictest youth-access prevention measures and age-verification policies when marketing our products to adults,” he said. “Our focus has always been the needs of the adult smoker while doing everything possible — including halting online sales — to ensure that minors are not able to access our products.
“The science demonstrating the value of quality ENDS products — inclusive of flavors — to help adult smokers who are unable or unwilling to entirely choose non-combustible alternatives is growing, not just here in the United States, but globally,” Patel said. “My hope is that here in the U.S., the FDA continues to evaluate the science and allows the data to drive future decisions. These advances should benefit adult smokers here in America, as well as smokers around the world.”
Bidi Vapor is in active communication with the FDA over the company’s PMTA for its 11 flavor varieties of the BIDI® Stick, including its tobacco and menthol products, Patel said.
ABOUT BIDI VAPOR
Based in Melbourne, Florida, Bidi Vapor maintains a commitment to responsible marketing, supporting age-verification standards and sustainability through its BIDI® Cares recycling program. The Company’s premier device, the BIDI® Stick, is a premium product made with medical-grade components, a UL-certified battery and technology designed to deliver a consistent vaping experience for adult smokers 21 and over. Bidi Vapor is also adamant about strict compliance with all federal, state and local guidelines and regulations. At Bidi Vapor, innovation is key to our mission, with the BIDI® Stick promoting environmental sustainability while providing a unique vaping experience to adult smokers.
For more information, visit www.bidivapor.com.